Otc - Active Ingredient
Menthol 0.44% w/w
Zinc Oxide 20.625% w/w
Claravie Ointment
FDA Label NDC 61554-306
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gentell Llc for the product Claravie (NDC 61554-306). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, inactive ingredient, warnings, otc - ask doctor, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
External Analgesic
Skin Protectant
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredient
Calamine, Glycerin, Lanolin, Light liquid Paraffin, Petrolatum, Thymol, Tocopheryl Acetate
Warnings
For external use only
- Not for deep or puncture wounds
- Avoid contact with eyes
Otc - Ask Doctor
Stop use and ask a doctor if
- Condition worsens
- Symptoms last more than 7 days or clear up and occur again within a few days
Dosage & Administration
Apply as recommended
Indications & Usage
A moisture barrier that prevents & helps heal skin irritation from :
urine
diarrhea
perspiration
fistula drainage
feeding tube site leakage
wound drainage (peri-wound skin)
minor burn
cuts
scrapes
itching
Otc - Questions
Store at room temperature 68-77 0 F (20-25 0 C)
* Please review the disclaimer below.
